China vaccine trial suspended after 'severe adverse event'

• Brazil's health regulator says it suspended clinical trials for Sinovac Biotech's (NASDAQ:SVA) coronavirus vaccine because of a "severe adverse effect" in a final-stage trial, marking the first serious setback for any of China's rapidly developed COVID-19 shots.
• The health regulator, Anvisa, did not specify whether the incident occurred in Brazil - where trials are being conducted - or in another country.
• China already has started administering vaccines, including  Sinovac's, to hundreds of thousands of people under an expansive emergency use approval, making the prospect of a safety issue being detected at this stage more concerning.
• Just three weeks ago, preliminary results indicated Sinovac's Coronavac had appeared to be safe in a late-stage clinical trial in Brazil.
• https://seekingalpha.com/news/3634137-china-vaccine-trial-suspended-after-severe-adverse-event
  

Amgen, AstraZeneca's tezepelumab meets primary endpoint in late-stage asthma study

• Amgen (NASDAQ:AMGN) and AstraZeneca (NASDAQ:AZN) announce positive topline results from the Phase 3 NAVIGATOR trial evaluating investigational medicine tezepelumab compared to placebo in patients with severe asthma.
• The NAVIGATOR trial met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful reduction compared to placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, regardless of eosinophil count.
• SoC was medium or high dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).
• Tezepelumab was very well tolerated and preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups.
• Tezepelumab blocks the action of thymic stromal lymphopoietin, an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.
• Results from the NAVIGATOR trial will be presented at an upcoming medical meeting.
• Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment of mid-single-digit royalty to Amgen.
• AstraZeneca continues to lead development and Amgen continues to lead manufacturing.
• https://seekingalpha.com/news/3634177-amgen-and-astrazenecas-tezepelumab-meets-primary-endpoint-in-late-stage-asthma-study
  

States, FDA Warn Of 'Careless' Rapid Antigen Testing In Asymptomatic COVID

As if there wasn't enough confusion and broad misunderstanding going around about Covid, the states of Louisiana and Oregon are now warning against using rapid, low cost antigen tests in asymptomatic people to try and determine whether or not they are positive with coronavirus. Oh, and so is the Food and Drug Administration...

The appeal of these tests is that they can be spread widely and cheaply, giving the illusion of control over the virus to individuals and organizations that use them for quick blanket testing.

But these tests could "miss some infections that can be picked up by costlier gold-standard assays, and can incorrectly return positive results," according to Bloomberg. 

As a result, the state is not recommending the tests to people without symptoms, who have not been exposed to someone with a positive test. The Louisiana Department of Health also says that people who undergo antigen tests should be made aware of its limitations. 

Joseph Kanter, interim assistant secretary for the state’s Office of Public Health, said: “On the one hand, we have technology and testing platforms like this one which are new and likely valuable. And everybody has an interest in getting them to people that could benefit from them as quick as possible. On the other hand, we don’t have great data on them yet.”

The Oregon Health Authority has also warned against using the tests in asymptomatic people without confirmed Covid-19 exposure.

Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, commented that antigen tests for one time use risks the chance of missing infections: “For people looking to one-time use of Covid antigen tests as a way to go back to normal, we’re not in that situation now. This is one more layer of protection as we try to reopen and get through the rest of the pandemic.”

On Tuesday, the FDA also warned about the tests, saying they can produce "incorrect positive results". Nursing homes and other care settings have reported false positives from antigen tests, the FDA noted. 

These warnings apply to tests like Abbot's $5 BinaxNOW test that the U.S. government is spending $750 million on. Now, state health officials are reportedly "increasingly concerned that people without symptoms should be screened with more costly but more reliable polymerase chain reaction assays". 

Jeff Engel, a senior adviser at the Council of State and Territorial Epidemiologists, said: "HHS made this purchase without any studies on the novel use in which they’re deploying these tests. I think that’s careless.”

It's also one of the infinite reminders that government is not only an abhorrent allocator of other peoples' capital, but is also flailing wildly in trying to control a virus that is casually making its way across the globe regardless of what preventative measures we take. 

HHS official Brett Giroir responded: “We do support asymptomatic testing being used. That is the only way that you’re going to screen millions of people a month.”

Abbot responded: "Widespread, affordable rapid antigen testing helps slow the virus’s spread, and tests like BinaxNOW, when used as intended, can detect those most likely to be infectious."

https://www.zerohedge.com/markets/multiple-states-and-fda-warn-careless-rapid-antigen-testing-asymptomatic-covid-cases

Endangering lives by blocking vaccines

Monday’s news that a COVID-19 vaccine from Pfizer will be ready for Food and Drug Administration approval this month sent stock markets soaring and everyone celebrating. It is wonderful news for all humanity.

A vaccine will slow the deaths, end the lockdowns, allow businesses to reopen, free children to return to school and return life to normal within half a year.

Amazingly, one group isn’t celebrating: Democratic politicians. They would sooner criticize the breakthrough than allow the triumph to occur on President Trump’s watch. Gov. Cuomo in New York and Gov. Gavin Newsom in California are saying FDA approval of the vaccine isn’t enough, and they will insist on approval by experts in their own states, as well.

That’s unconstitutional. Drug approval is a federal responsibility, and courts have ruled that states should stay out of it.

Cuomo took it a preposterous step further on Monday, arguing that it would have been better if the vaccine had been delayed until Joe Biden became president. With over 1,000 Americans dying a day from COVID-19, Cuomo’s political calculation makes no sense.

Pfizer and its German biotech partner, BioNTech, announced that their vaccine appears to be 90 per­cent effective against the virus — a stunning achievement. The FDA minimum level of efficacy is 50 percent, which is standard also for flu vaccines. Pfizer’s vaccine will offer far more protection. Once Pfizer wins approval, it will sell 20 million doses a month to the United States government, also supply the European Union and Japan and eventually produce over 1.3 billion doses.

More good news. Another vaccine developer, Moderna, using a technology similar to Pfizer’s, will announce its data later this month. Moderna’s likely approval will mean there will probably be sufficient production of vaccines in 2021 to stop this virus worldwide.

No wonder airline, cruise-ship and restaurant stocks soared by double digits. A vaccine will allow people to travel, dine out and resume life as they knew it pre-COVID-19. Thanks to science, the “new normal” won’t become a permanent reality.

If only science could cure politicians’ cynicism. The big lie that drove the election was that Trump was to blame for 230,000 deaths. Biden assailed Trump for opening the economy and vowed to shut it down again. Biden promised to get control of the virus, but he never specified what he’d do differently. It was Trump who had the vision to focus on vaccine development.

Biden and Harris vowed they wouldn’t trust a vaccine offered by Trump. These petty comments increased the risk that the public will hesitate to get vaccinated.

Ironically, as news broke about Pfizer’s vaccine, Biden announced his coronavirus task force and outlined his plans to ramp up testing, contact tracing and other defensive measures. Aside from mask wearing, it was hard to see any daylight between what he recommended and what Trump has been doing for months. Biden barely mentioned the vaccine — the game changer that will eventually make all these other measures unnecessary.

Meanwhile, Cuomo bashed Team Trump’s vaccine-distribution plan for neglecting needy groups and suggested New Yorkers should wait for a vaccine until Biden takes office.

The truth is, Trump will distribute the vaccine for free to the general public at retailers like CVS and Walmart. That’s sensible, because the public is accustomed to going there for flu vaccines. But health workers, nursing-home residents, the homeless and other vulnerable groups will also get priority.

Cuomo, who has blood on his hands for forcing COVID-19 patients into nursing homes, now wants New Yorkers to wait months longer than residents of other states for a vaccine. Tell that to elderly people who have been trapped in their homes for months.

No matter what your politics, the vaccine breakthrough is a relief. Trump deserves credit. He urged the pharmaceutical giants to invest in vaccine development, committed to buying the vaccines to remove the business risk and streamlined FDA regulations to speed the process without compromising safety.

A weary world should be grateful. Well done, Mr. President.

Betsy McCaughey is a former lieutenant governor of New York. 

https://nypost.com/2020/11/09/trump-deranged-democrats-endanger-lives-by-blocking-vaccines/

Pfizer and Biontech snatch first Covid vaccine victory

News that Pfizer and Biontech’s Covid-19 vaccine candidate sailed through its first pivotal trial interim efficacy analysis sent shares soaring today – and not only in those two companies. Confirmation that protection against the pandemic could start rolling out before the end of the year sent global stock markets higher, lifting sectors from airlines to retailers.

With efficacy coming in at greater than 90% it seems pretty certain that BNT162b2 offers protection against the coronavirus that causes Covid-19. But it should be remembered that this is only a brief glimpse of the results. A more detailed breakdown of the data, and later cuts, remain crucial, while safety too has yet to be confirmed.

But, for the first late-stage readout from the clutch of Covid-19 vaccines in development, the news could not have been much more positive. Expectations among the financial community had sat at around 70% efficacy, while the FDA had set a 50% threshold for any project to qualify for consideration of early approval.

Shares in Pfizer were 6% higher in early trade, while Biontech, which contributed the mRNA technology on which the vaccine is based, jumped 12%.

Other leading vaccine developers also reacted: Astrazeneca, which is expecting its first pivotal readout in December, dropped 3%, while Novavax climbed 6%. Up 7% was Moderna, the other developer with a late-stage mRNA-based project, mRNA-1273; some might be betting that BNT162b2’s success raises chances here.

Important differences between all of these assets make that very hard to assume, however. With Moderna promising a first readout in the coming weeks, comparisons will soon become easier to make.

First peek

The 90% efficacy figure was derived from 94 cases, which implies 86 infections in the placebo cohort and 8 in those who received the vaccine. This was measured at seven days after the second dose, pointing to protection 28 days after the first shot, the companies said.

The statement also contained news that, in agreement with the FDA, the groups decided against conducting the first planned interim analysis, which was supposed to happen after the first 32 infections according to the initial protocol. It is not clear why this decision was taken, though many will note that it pushed the first readout beyond the US Presidential election.

Politics aside, at least this explains the apparent delay to the first interim analysis, which caused some concern two weeks ago. Efficacy thresholds of 77% and 68% had been set for these first two analyses, which have easily been beaten.

The next hurdle will be a safety analysis to satisfy the terms of any US emergency use authorisation; these data remain on track for the third week of November. After filing the FDA will convene an advisory committee, likely in December, with approval expected before the end of the year. In Europe, a rolling review has already commenced, pointing to a similar timeframe for regulatory action.

Final cut

The final analysis will happen once 164 Covid-19 infections have been confirmed among the 40,000-plus participants in the trial. whcih should be easily beaten. There is a good chance that these will have occurred by the time the FDA gets hold of the data, and the regulator and its assembled experts will be very keen to review a full package. 

This should include the extent to which the vaccine prevented severe infections – nothing was said on this in today’s release. The protection afforded to more vulnerable populations is another important measure; if infections are still being seen in the elderly, for example, the product’s utility could be questioned.

Safety, of course, remains crucial. No serious safety concerns have been reported, the companies said today, but a more detailed look at adverse events is needed.

Still, it seems likely that BNT162b2 will be the first Covid-19 vaccine to reach the market in the West. Its commercial potential remains hard to know until the durability of protection is confirmed – another big unknown here – and before rival projects report.

However huge numbers are already being mooted. Mizuho analysts said today they expect more than $8.5bn in revenues in 2020-21.

The final barrier that Pfizer must overcome is distribution, given that BNT162b2 must be transported and stored at -70C. That is a problem for tomorrow, however, and for now the world is celebrating very impressive results achieved at breakneck speed.

https://www.evaluate.com/vantage/articles/news/trial-results/pfizer-and-biontech-snatch-first-covid-vaccine-victory

FDA OKs Wearable Treatment for Nightmares

The FDA gave marketing authorization to an Apple Watch app that detects and disrupts nightmares for adults with post-traumatic stress disorder (PTSD) or nightmare disorder, the agency announced Friday.

The so-called NightWare system uses an algorithm that creates a unique sleep profile for each patient based on disruptions in body movements and heart rate. Apple Watch sensors monitor the patient's sleep, sending data to the manufacturer's server which then determines when the patient is having a nightmare. The watch responds by vibrating enough to disrupt the nightmare, typically without fully waking the user.

Patients who experience sleepwalking or violence during nightmares should not use the device, however, and users should contact their doctors if daytime sleepiness persists or if nightmares worsen, according to the FDA.

People with PTSD or a nightmare disorder are often sleep-deprived, said Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, in a statement Friday.

"Today's authorization offers a new, low-risk treatment option that uses digital technology in an effort to provide temporary relief from sleep disturbance related to nightmares," Peña said.

Nightmares of this nature have been associated with increased rates of suicide, heart disease, and other mental health conditions.

The American Academy of Sleep Medicine (AASM) recommends a variety of atypical antipsychotics and tricyclic antidepressants for treating nightmare disorder and PTSD, along with cognitive behavioral therapy.

The system, developed by Minneapolis-based NightWare, is intended to be prescribed along with pharmacotherapy for PTSD and nightmare disorder, the agency stated.

The concept was first developed by a college student seeking to help his father, a U.S. Army sergeant who suffered from PTSD nightmares, said Grady Hannah, NightWare's chief executive officer.

The technology follows the model of service dogs that can be trained to wake their owners during nightmares by licking their face or turning on the lights, Hannah said.

"The nice part about the device is we arouse users enough to take them out of the nightmare, but don't wake them up enough to disrupt sleep," Hannah told MedPage Today.

NightWare is one of many digital therapeutics recently approved to treat mental health conditions. In March, the FDA granted authorization to Somryst, a smartphone-based therapy for insomnia under the same 510(k) premarket process, through which all future digital therapeutics of this nature will pass.

The FDA granted NightWare breakthrough device designation and reviewed it through an expedited process intended for low to moderate risk devices.

Findings from a 30-day trial were key to the agency's decision. Patients wearing a vibrating device showed significantly improved scores on the Pittsburgh Sleep Quality Index scale compared to a sham-controlled group of patients who wore inert devices.

No changes in suicidality and sleepiness occurred in any patients involved in the trial.

NightWare is conducting additional research at Veteran's Affairs hospitals in an ongoing clinical trial, and has plans to conduct a 400-person virtual study.

https://www.medpagetoday.com/psychiatry/sleepdisorders/89560